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U.S. Department of Health and Human Services

Class 1 Device Recall UniCel DxC Synchron Clinical System

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 Class 1 Recall
UniCel DxC Synchron Clinical System
see related information
Date Posted March 04, 2010
Recall Status1 Terminated on April 17, 2012
Recall Number Z-0863-2010
Recall Event ID 54344
Premarket Notification
510(K) Numbers
K042291  K060256 
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
Product Beckman Coulter UniCel DxC Synchron Clinical System ISE Flow Cell. PN Numbers: A10405 (UniCel DxC 600); A11810 (UniCel DxC 600 PRO); A27318 (UniCel DxC 600i); A11816 (UniCel DxC 800); A11812 (UniCel DxC 800 PRO); A59102 (UniCel DxC 880i); A64903 (UniCel DxC 680i); A64871 (UniCel DxC 660i); A64871 (UniCel DxC 860i). Intended for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries of clinical interest in biological fluids such as serum, plasma, urine, or cerebrospinal fluid.
Code Information All serial numbers. PN Numbers: A10405 (UniCel DxC 600); A11810 (UniCel DxC 600 PRO); A27318 (UniCel DxC 600i); A11816 (UniCel DxC 800); A11812 (UniCel DxC 800 PRO); A59102 (UniCel DxC 880i); A64903 (UniCel DxC 680i); A64871 (UniCel DxC 660i); A64871 (UniCel DxC 860i); and A64935 (UniCel DxC 860i).
Recalling Firm/
Manufacturer
Beckman Coulter Inc.
200 S Kraemer Blvd
Brea, California 92821-6208
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Excessive Buildup of protein, bacteria and sample tube additives in the ISE flow cell may cause erroneous NA (sodium) results.
FDA Determined
Cause 2
DESIGN: Device Design
Action An Urgent: Product Corrective Action letter dated January 4, 2010, was mailed to customers advising of erroneous sodium results derived from build up of protein, bacteria and additives in the ISE flow cell. The letter discussed the impact and actions to be taken along with some additional recommendations. Customers are advised to follow the new maintenance instructions included with the letter. The information in the letter should be shared with laboratory staff and the notification should be retained as part of the Quality System documentation. A copy of the letter should be provided to any other laboratory that affected product was forwarded to. The enclosed response form should be completed and returned. Questions should be directed to the Customer Support Center at 1-800-854-3633.
Quantity in Commerce 2630
Distribution Worldwide Distribution -- USA and Canada.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JJE and Original Applicant = BECKMAN COULTER, INC.
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